Regulation of TFA (Pdf to Save or Print) - Food Safety and Standards ...
Regulation of TFA (Pdf to Save or Print) - Food Safety and Standards ...
Regulation of TFA (Pdf to Save or Print) - Food Safety and Standards ...
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2Risk Assessment Rep<strong>or</strong>t on <strong>TFA</strong>s in Indian Diets submitted by National Institute <strong>of</strong>Nutrition, Hyderabad in Oc<strong>to</strong>ber, 20094. On the request <strong>of</strong> FSSAI, NIN carried out a risk analysis <strong>of</strong> transfats in the Indi<strong>and</strong>iet. A summary <strong>of</strong> the findings <strong>of</strong> the rep<strong>or</strong>t is as under:-(a) Not m<strong>or</strong>e than 10% (7% f<strong>or</strong> those with cardiac problems) <strong>and</strong> 1% <strong>of</strong> <strong>to</strong>talenergy can be derived from saturated fat <strong>and</strong> <strong>TFA</strong>, respectively acc<strong>or</strong>ding <strong>to</strong> currentscientific research <strong>and</strong> WHO recommendations, if risk <strong>of</strong> cardio- vascular diseasehas <strong>to</strong> be kept at safe levels. It is imp<strong>or</strong>tant f<strong>or</strong> population <strong>and</strong> individual health that<strong>TFA</strong>s should be removed from the food supply <strong>and</strong> should be replaced by cisunsaturatedfats from vegetable oils rather than saturated fats from tropical oils <strong>and</strong>animal fats.(b) In rural <strong>and</strong> urban India the fat consumption is around 20 <strong>and</strong> 30g /day,respectively, acc<strong>or</strong>ding <strong>to</strong> diet studies (National Consumption Survey data). If 10%<strong>TFA</strong> is permitted in vanaspati, a person consuming 2000Kcal derived from foodwhich contains 20 <strong>and</strong> 30g vanaspati/day will derive 0.9 <strong>and</strong> 1.35 % energy from the<strong>TFA</strong>. (This shows that even at 10% <strong>TFA</strong> level there is health risk at 30g <strong>of</strong> vanaspaticonsumption per day (which exceeds the 1% energy, which is the limit f<strong>or</strong> <strong>TFA</strong>recommended by WHO).(c) Attempts <strong>to</strong> bring down the levels <strong>of</strong> <strong>TFA</strong>s in PHVOs by completehydrogenation <strong>or</strong> higher levels <strong>of</strong> hydrogenation will result in elevated melting point<strong>and</strong> SFA content. This has <strong>to</strong> be viewed with caution as elevation <strong>of</strong> SFAs invanaspati obtained from complete hydrogenation would result in increase in % <strong>of</strong>energy derived from SFAs (not m<strong>or</strong>e than 7% <strong>of</strong> <strong>to</strong>tal energy is <strong>to</strong> be derived fromsaturated fat as recommended by WHO). Increase in intake <strong>of</strong> SFAs will lead <strong>to</strong>increase in serum cholesterol levels <strong>and</strong> Low Density Lipoprotein (LDL) which arepotential risk fac<strong>to</strong>rs f<strong>or</strong> CHD.5. The W<strong>or</strong>ld Health Assembly resolved in 2004 that elimination <strong>of</strong> <strong>TFA</strong> should be akey point f<strong>or</strong> action by governments. WHO/FAO has recently completed an extensivereview <strong>of</strong> latest research on the links <strong>of</strong> <strong>TFA</strong> <strong>to</strong> CVD <strong>and</strong> diabetes <strong>and</strong> recommended thatall countries should take urgent regula<strong>to</strong>ry steps <strong>to</strong> limit transfats in their diet so that cleardanger <strong>to</strong> heart health in vulnerable groups is avoided. Acc<strong>or</strong>ding <strong>to</strong> a rep<strong>or</strong>t in New
3Engl<strong>and</strong> Journal <strong>of</strong> Medicine (Mozaffarian et al, 2006) consumption <strong>of</strong> transfats result inconsiderable potential harm with no benefit. National Academy <strong>of</strong> Sciences, USA hasconcluded that there is no safe level <strong>of</strong> <strong>TFA</strong> consumption, no recommended daily amoun<strong>to</strong>r <strong>to</strong>lerable upper limit as any incremental increase in <strong>TFA</strong> increases the risk <strong>of</strong> c<strong>or</strong>onaryheart disease.6. The implications <strong>of</strong> replacing high <strong>TFA</strong> partially hydrogenated oil by substituteswere also considered by FSSAI. While the availability <strong>of</strong> alternative sources <strong>of</strong> fats is notlikely <strong>to</strong> be a problem, test results <strong>of</strong> the fatty acids pr<strong>of</strong>ile in the market indicate thattechnological solutions are available f<strong>or</strong> reducing trans fats <strong>to</strong> acceptable limits. Industrymay require a suitable time frame f<strong>or</strong> adopting these practices <strong>and</strong> healthier alternatives.Supp<strong>or</strong>t should be given <strong>to</strong> industry <strong>to</strong> communicate the healthier nature <strong>of</strong> its products <strong>to</strong>consumers <strong>and</strong> also help small <strong>and</strong> medium sized enterprises <strong>to</strong> prepare f<strong>or</strong> compliance.The vegetable oil industry should take the lead in this area.7. The experience <strong>of</strong> other countries who have introduced regulation <strong>to</strong> limit trans fatsindicate that Polyunsaturated fatty acids including alpha-linolenic (Omega 3) <strong>and</strong> linoleic(Omega 6) acids are also imp<strong>or</strong>tant components <strong>of</strong> a cholesterol lowering <strong>and</strong> m<strong>or</strong>ehealthful diet. However, the benefits depend <strong>to</strong> some degree on consuming anappropriate balance <strong>of</strong> these fatty acids. The goal, theref<strong>or</strong>e, should be <strong>to</strong> replace, asmuch as possible, trans saturated fats with mono unsaturated fats <strong>and</strong> maintain adequateintake <strong>and</strong> appropriate balance <strong>of</strong> Omega 6 <strong>and</strong> Omega 3 polyunsaturated fatty acids.8. It is also necessary <strong>to</strong> consider appropriate modifications in the edible oilsregulations <strong>to</strong> encourage use <strong>of</strong> all available healthier alternatives. Further research onthese possibilities need <strong>to</strong> be undertaken so that available options are considered <strong>and</strong>appropriate regulations are developed.Current regulations f<strong>or</strong> <strong>TFA</strong>s9. The PFA Rules, 1955 require that:-(a) The foods in which hydrogenated vegetable fats <strong>or</strong> bakery sh<strong>or</strong>tening is usedshall declare on the label that “Hydrogenated vegetable fats <strong>or</strong> bakerysh<strong>or</strong>tening used-contains trans fats”.
5Proposed regulations under FSSAI13. The need was felt <strong>to</strong> regulate the <strong>TFA</strong>s in partially hydrogenated vegetable oils <strong>and</strong>this issue was considered in the Third meeting <strong>of</strong> the <strong>Food</strong> Auth<strong>or</strong>ity held on 26 thNovember, 2009 where it was recommended <strong>to</strong> fix a limit <strong>of</strong> not m<strong>or</strong>e than 10 percenttrans-fatty acids in partially hydrogenated vegetable oils. It was also recommended that anational consultation may also be <strong>or</strong>ganized <strong>to</strong> obtain feedback from consumers <strong>and</strong>industry <strong>and</strong> the scientific community f<strong>or</strong> implementation <strong>of</strong> the regulation.14. In view <strong>of</strong> above, National Institute <strong>of</strong> Nutrition, Hyderabad conducted a nationalconsultation by inviting participants representing all stakeholders on 29.01.2010 whichrecommended the following with regard <strong>to</strong> <strong>TFA</strong> limits :-(a) The <strong>TFA</strong> level in PHVO should be below 10% <strong>and</strong> should not exceed 10%.(b) Existing melting point regulation which is 31°C - 41°C f<strong>or</strong> partially hydrogenatedvegetable oils, bakery sh<strong>or</strong>tening <strong>and</strong> margarines, interesterified vegetable fat<strong>and</strong> other fats made using vegetable oils should be removed in harmonizationwith Codex St<strong>and</strong>ard.(c) Natural hard fractions like Palm Stearin should be included in list <strong>of</strong> edible oils<strong>and</strong> fats in line with Codex St<strong>and</strong>ard.(d) M<strong>and</strong>a<strong>to</strong>ry labelling <strong>of</strong> <strong>TFA</strong> <strong>and</strong> saturated fat content f<strong>or</strong> all edible oils <strong>and</strong> fatsshould be implemented.(e) PFA regulation must allow both chemical <strong>and</strong> enzymatic inter esterification.15. Thereafter the issue was considered in the meeting <strong>of</strong> Central Advis<strong>or</strong>y Committee<strong>and</strong> Scientific Committee <strong>of</strong> <strong>Food</strong> Auth<strong>or</strong>ity which end<strong>or</strong>sed the recommendation <strong>of</strong> a limit<strong>of</strong> 10 % <strong>TFA</strong> in vanaspati <strong>to</strong> be brought down <strong>to</strong> 5% within a period <strong>of</strong> three years.16. An Expert Group constituted by FSSAI also deliberated on the need f<strong>or</strong> fixing the<strong>TFA</strong> limit in vanaspati <strong>and</strong> recommended that level <strong>of</strong> <strong>TFA</strong> in Vanaspati / PHVO, be fixedat the level 10% maximum, <strong>to</strong> be brought down <strong>to</strong> 5% in 3 years. The Expert Group alsosuggested change in the regulations regarding melting point <strong>and</strong> enzymatic esterificationf<strong>or</strong> production <strong>of</strong> vanaspati f<strong>or</strong> regulating trans fatty acids.
617. A large prop<strong>or</strong>tion <strong>of</strong> population in Indian sub continent is identified as geneticallypre-disposed <strong>to</strong> CVD. Consumption <strong>of</strong> vanaspati <strong>and</strong> <strong>TFA</strong> compound the risk <strong>of</strong> CVD inIndian population. It seems appropriate, theref<strong>or</strong>e, that steps are taken in our country <strong>to</strong>minimize the <strong>TFA</strong> intake through dietary fat.18. Taking in<strong>to</strong> account all the above mentioned inputs, the FSSAI proposes thefollowing :-(a)Level <strong>of</strong> <strong>TFA</strong> in Vanaspati / PHVO, be fixed at 10% maximum <strong>and</strong>brought down <strong>to</strong> 5% in 3 years. A phasing in period may be given <strong>to</strong>industry after the date <strong>of</strong> notification. A detailed review <strong>of</strong> the impact <strong>of</strong>the measure should be carried out by the end <strong>of</strong> 3 years <strong>to</strong> decidewhether further reduction can be attempted.(b)There are no substantial studies on detrimental effects <strong>of</strong> raising themelting point <strong>of</strong> vanaspati from current level <strong>of</strong> 41 0 <strong>to</strong> 51 0 <strong>or</strong> <strong>to</strong> removethe melting point limit al<strong>to</strong>gether. On the other h<strong>and</strong>, it has beenargued that high melting point has no deleterious effect on health <strong>or</strong>digestion. N<strong>or</strong> do Codex st<strong>and</strong>ards prescribe an upper limit on meltingpoint. There is need <strong>to</strong> carry out studies f<strong>or</strong> documenting the effects <strong>of</strong>raising / removing the melting point limit on digestion <strong>and</strong> overallhealth. It is, theref<strong>or</strong>e, proposed that presently status quo may bemaintained i.e. melting point <strong>of</strong> 41°C be retained <strong>or</strong> it be raised only <strong>to</strong>the extent that would facilitate bringing down the <strong>TFA</strong> level <strong>to</strong> theabove limits.(c)There is also a need <strong>to</strong> look in<strong>to</strong> the feasibility f<strong>or</strong> laying down thelimits <strong>of</strong> Saturated Fatty Acids (SFAs) in vanaspati <strong>and</strong> other fats. Thisis being thought <strong>of</strong> because if the melting point is raised, it will lead <strong>to</strong>increase in saturation <strong>of</strong> partially hydrogenated vegetable oils. WHOhad recommended that not m<strong>or</strong>e than 1% <strong>and</strong> not m<strong>or</strong>e than 10% <strong>of</strong>energy in diet be derived from <strong>TFA</strong>s <strong>and</strong> SFAs, respectively.(d)Enzymatic esterification f<strong>or</strong> production <strong>of</strong> vanaspati f<strong>or</strong> regulating transfatty acids can be considered. But it being a costly alternative, maytake time f<strong>or</strong> implementation.
7(e)(f)(g)As regards permitting use <strong>of</strong> Palm Stearin in vanaspati, it also needs <strong>to</strong>be looked in<strong>to</strong> whether <strong>to</strong> allow its use <strong>or</strong> not as in our country PalmStearin is used in soap industry. However, there was no safety issue onits use <strong>and</strong> it is allowed in Codex st<strong>and</strong>ards with melting point <strong>of</strong>44°C - 52°C. Palm Stearin after interesterification with another liquidoil like rice bran oil, mustard oil, sunflower oil <strong>or</strong> soybean oil inappropriate ratio is shown <strong>to</strong> produce sh<strong>or</strong>tening similar <strong>to</strong> vanaspatiwith comparable functional properties <strong>and</strong> the product is completelyfree from trans fatty acids. However, Palm Stearin content may bepermitted only in interesterified fat <strong>and</strong> not approved f<strong>or</strong> blending <strong>of</strong>oils <strong>or</strong> <strong>to</strong> be used as such.There should be m<strong>and</strong>a<strong>to</strong>ry labelling <strong>of</strong> <strong>TFA</strong> & SFA content onvanaspati packs, edible oils <strong>or</strong> any other product containing <strong>TFA</strong> fromvanaspati sources. This is necessary <strong>to</strong> enable inf<strong>or</strong>med choice byconsumers.There is currently a limit on blending <strong>of</strong> m<strong>or</strong>e than two oils <strong>and</strong> aminimum requirement <strong>of</strong> 20% f<strong>or</strong> each oil used f<strong>or</strong> blending. Theselimits have been imposed <strong>to</strong> facilitate detection <strong>of</strong> adulteration. Thereis a dem<strong>and</strong> f<strong>or</strong> reviewing this restriction <strong>to</strong> facilitate greater use <strong>of</strong>other oils by industry <strong>and</strong> facilitate balance in SFA : MUFA : PUFAcomponents.19. The above recommendations are likely <strong>to</strong>:(a) Contribute <strong>to</strong> decreasing / removing one <strong>of</strong> the risk fac<strong>to</strong>rs <strong>and</strong>significantly improve the heart health <strong>of</strong> Indian citizens <strong>and</strong> save lives.(b) Reduce daily intake <strong>of</strong> transfats by Indian consumers <strong>of</strong> all age groups<strong>to</strong> between 1% <strong>and</strong> 2% <strong>of</strong> energy intake consistent with current dietaryrecommendations, over a period <strong>of</strong> 3 years.(c) Those at the highest consumption level will benefit from them<strong>and</strong>a<strong>to</strong>ry reduction <strong>of</strong> industrially produced trans fats. Even those with lowconsumption will benefit. Even if small amounts <strong>of</strong> fat is consumed, if it isdevoid <strong>of</strong> <strong>TFA</strong> <strong>and</strong> contains unsaturated fatty acids, the population will st<strong>and</strong><strong>to</strong> benefit.
8(d) Promote the development <strong>of</strong> alternative supplies <strong>of</strong> m<strong>or</strong>e healthfulalternatives <strong>of</strong> trans fats.(e) Provide a level playing field <strong>to</strong> industry <strong>to</strong> compete on the basis <strong>of</strong> thesafety <strong>and</strong> healthy features <strong>of</strong> their products.20. Keeping in view the imp<strong>or</strong>tance <strong>of</strong> the proposed measure in improving health <strong>and</strong>reducing the risk <strong>of</strong> cardiovascular disease <strong>to</strong> a large section <strong>of</strong> the population, <strong>Food</strong><strong>Safety</strong> <strong>and</strong> St<strong>and</strong>ards Auth<strong>or</strong>ity believes that the proposed measure should be widelydisseminated f<strong>or</strong> feedback from all stakeholders. Those desirous <strong>of</strong> commenting on theproposed measure are invited <strong>to</strong> send their comments within 30 days from publishing <strong>of</strong>this note <strong>to</strong> <strong>Food</strong> <strong>Safety</strong> <strong>and</strong> St<strong>and</strong>ards Auth<strong>or</strong>ity. Thereafter, <strong>Food</strong> <strong>Safety</strong> <strong>and</strong> St<strong>and</strong>ardsAuth<strong>or</strong>ity proposes <strong>to</strong> finalise the regulations f<strong>or</strong> submission <strong>to</strong> the Government.Please send your comments <strong>to</strong> :Name : Dr. Dhir Singh, ADG(PFA)E.mail : adgpfa@nb.nic.inContact No. : 23237418Fax No. : 23220994